Extensive experience drafting, editing and coordinating the preparation regulatory submissions relating to new drugs (small and large molecules) and medical devices (Class I, II and III).

Biopharmaceutical submission experience includes:

Investigational New Drug (IND), New Drug Applications (NDA) and Biologics License Applications (BLA), including:

·        Chemistry, Manufacturing & Control (CMC) sections

o        Chemical characterization

o        Manufacturing process descriptions

o        Analytical methods qualification and/or validation reports

o        Equipment validation (Installation, Operational and Performance Qualification, IQ, OQ & PQ)

·         Nonclinical study sections

·         Investigator Brochures

·        Clinical Research sections

o        Clinical Plans

o        Clinical Protocol drafting with GCP compliance assessments

o        Informed Consent forms

o        Case Report Forms (CRFs)

Responses to FDA Comments/ IND, NDA and BLA submissions

Medical Device submission experience includes:

• Drafting Design Control / Design History Files including regulatory justification for device changes ( "Letters to File")

• Premarket Notifications (510K):

o        Traditional 510K application

o        Special 510K application

o        Abbreviated 510K applications

• Investigational Device Exemption (IDE) applications

• Pre-market approval (PMA) applications

• Device reclassification petitions

• Master files

• Foreign filings with a wide variety of European countries (IECs and Government bodies)  in support of applications for clinical  investigations

• Technical files and Design Dossiers for EC marketing